The Corin Unipolar Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

Device Description

The Corin Unipolar Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is designed to be used with a number of femoral hip stem designs which incorporate a compatible male taper. The Corin Unipolar Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm and a variety of offsets.

AI/ML Overview

Please find below the requested information regarding the acceptance criteria and study details for the Corin Unipolar Modular Head, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Composition	Manufactured from Cobalt-Chrome alloy conforming to ASTM F75.
Geometry	Polished, truncated sphere with a high tolerance internal female taper.
Dimensional Range (Diameters)	Available in diameters ranging from 40-56mm. This range falls within those cleared for predicate devices (ULTIMA and Unitrax).
Dimensional Range (Offsets)	Available in a variety of offsets. This range falls within those cleared for predicate devices (Unitrax).
Taper Compatibility	Designed to be used with femoral hip stem designs incorporating a compatible male taper. Internal taper substantially equivalent to Howmedica Osteonics Unitrax C-Taper Neck Adjustment Sleeves and Osteonics Ion Implanted Femoral Bearings.
Mechanical Performance	Demonstrated through Finite Element Analysis, mechanical fatigue testing, and mechanical axial pull-off.
Safety and Effectiveness	Results of non-clinical testing and analysis show the device is "expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance

The document explicitly states: "Non-Clinical Testing: Non-clinical testing and analysis included Finite Element Analysis, mechanical fatigue testing, mechanical axial pull-off and dimensional comparison." No specific sample size for a "test set" in the context of clinical data is mentioned, as the evaluation was based on non-clinical engineering and material testing. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable to this type of testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The evaluation relied on engineering and material testing standards, not clinical expert consensus for ground truth.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" was based on established engineering principles, material standards (e.g., ASTM F75), and the performance characteristics of legally marketed predicate devices. The objective was to demonstrate substantial equivalence, meaning the new device performs similarly to or better than existing, cleared devices.

8. The sample size for the training set

Not applicable. This device's evaluation did not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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APR - 3 2007

长06319|

510(K) SUMMARY 3.

1. Applicant/Sponsor:	Corin USA10500 University Center DriveSuite 190Tampa, Florida 33612Establishment Registration No.: 1056629
2. Contact Person:	Kathy K. Trier, Ph.D.Director Clinical and Regulatory AffairsCorin USA813-977-4469kathy.trier@coringroup.com
3. Proprietary Name:	Corin Unipolar Modular Head
4. Common Name:	Unipolar Modular Head

Classification Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21CFR 888.3360)
Legally Marketed Devices to which Substantial Equivalence is claimed:

a. Johnson & Johnson ULTIMA Unipolar Modular Heads (K940190)
b. Howmedica Unitrax Unipolar System (K902365)
c. Howmedica Osteonics Unitrax C-Taper Neck Adjustment Sleeve (K992570)
d. Osteonics Ion Implanted Femoral Bearings (K910988)

7. Device Description:

. 8. Intended Use / Indications:
The Corin Unipolat Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and

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abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

1. Summary of Technologies/Substantial Equivalence:
  The Corin Unipolar Modular Heads have the same intended use and indications and are manufactured from the same materials as the predicate Johnson & Johnson ULTIMA Unipolar Heads and Howmedica Unitrax Unipolar System. The range of diameters available falls within the range cleared for the ULTIMA and Unitrax devices. The range of offsets available falls within the range cleared for the Unitrax devices. The Corin Unipolar Modular Heads have an internal taper that is substantially equivalent to the internal taper of the Howmedica Osteonics (110w Strykcr Orthopaedics) Unitrax C-Taper Neck Adjustment Sleeves and the Osteonics (now Stryker Orthopaedics) Ion Implanted Femoral Bearings. Based on these similarities, Corin believes that the Unipolar Heads are substantially equivalent to these predicate devices.
1. Non-Clinical Testing:
  Non-clinical testing and analysis included Finite Element Analysis, mechanical fatigue testing, mechanical axial pull-off and dimensional comparison. The results of this testing and analysis show that the Corin Unipolar Modular Head is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate devices.

11. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Corin Unipolar Modular Head and the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2007

Corin USA c/o Kathy K. Trier, Ph.D. Director, Clinical and Regulatory Affairs 10500 University Center Drive Suite 190 Tampa, Florida 33612

Re: K063791

Trade/Device Name: Corin Unipolar Modular Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL Dated: March 13, 2007 Received; March 15, 2007

Dear Dr. Trier:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the ericlosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality

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Page 2 - Kathy K. Trier, Ph.D.

systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. ection provisions (000000 begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Sincerely yours,

Karlao Buehup
to

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2. INDICATIONS FOR USE

510(k) Number (if known): _ K063791

Device Name: Corin Unipolar Modular Head

Indications for Use:

The Corin Unipolar Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or tevision femoral stern applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, theumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbare Buchurs
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
K063791

5100

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.